Review article: bismuth-based therapy for Helicobacter pylori eradication in children.

BACKGROUND: Because of the decrease in the Helicobacter pylori eradication rate after standard triple therapy with a proton pump inhibitor and two antibiotics, bismuth-based therapy has recently been recommended as alternate first-line regimen in children. AIM: To comprehensively review the clinical, pharmacologic and microbiologic properties of bismuth salts, and to summarise the evidence for the therapeutic efficacy of bismuth-based therapy for H. pylori eradication in children. METHODS: Bibliographical searches were performed in MEDLINE. Results on the efficacy of bismuth-containing regimens on H. pylori eradication were combined using the inverse variance method. RESULTS: Bismuth monotherapy showed a very low efficacy. Overall, the mean eradication rate with bismuth-based dual therapy was 68% (95% CI, 60-76%) (intention-to-treat analysis-ITT) and 73% (95% CI, 64-81%) (per protocol-PP). In case series, the overall percentages of children with successful eradication for triple therapy containing bismuth were 82% (95% CI, 76-88%) and 86% (95% CI, 80-92%) according to ITT and PP respectively. In comparative studies, H. pylori eradication rates ranged between 69% and 85% according to ITT and between 74% and 96% PP. Side effects included dark stools, urine discoloration, black tongue, burning tongue, and marked darkness of the gums. CONCLUSIONS: The evidence in favour of bismuth compounds for treating infected children is still not clear. Well-designed, randomised, multi-centre studies of H. pylori eradication trials in children comparing bismuth-based triple therapy with the best available recommended first-line therapies are needed. The evidence obtained from audited case series that produce an eradication rate of >95% on PP analysis should also be considered.